FDA Recalls Non-Sterile Fentanyl-Bupivacaine-Baclofen Injection
Med Shop Total Care Inc. is voluntarily recalling one lot of fentanyl-bupivacaine-baclofen injectable solution due to non-sterility concerns. The product was distributed in Texas and Puerto Rico.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 per the rubric. Non-sterility of injectable medications poses a significant risk of serious infection and harm when administered, even without reported illnesses in the source text.
Plain-English summary
Med Shop Total Care Inc. is voluntarily recalling lot #09282020@75 of fentanyl-bupivacaine-baclofen injectable solution (575 mcg fentanyl, 18 mg bupivacaine HCL, 6000 mcg baclofen per mL) in 21 mL syringes. The recall was initiated on October 5, 2020, and classified by the FDA as Class I on August 9, 2021.
The reason for the recall is non-sterility of the product. Injectable medications must be sterile to prevent infection and other serious complications when administered.
The affected product was distributed to Texas and Puerto Rico. Healthcare providers and patients who have received this medication should consult with their healthcare provider immediately.
The recall status is terminated as of August 17, 2023.
The recalled product
- Product
- FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
- Manufacturer
- Med Shop Total Care Inc.
- Category
- Drug — Injectable / Parenteral
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 09282020@75 BUD: 10/27/2020
Distribution
Part of a larger recall action
This product is one of 14 recalled by Med Shop Total Care Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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